This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.
The primary objective of this study is to evaluate the natural course of low-risk papillary thyroid cancer, specifically the progression rates of tumor size increase and the occurrence of local or distant metastasis. Ultimately, it is expected that establishing new criteria for active surveillance of low-risk papillary thyroid cancer in Korean patients will lead to a reduction in unnecessary surgical treatments, improving quality of life and decreasing national healthcare costs.
Study Type
OBSERVATIONAL
Enrollment
499
National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
SMC-SNU Boramae Medical Center
Seoul, South Korea
Rate of disease progression between the active surveillance group and the immediate surgery group
Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.
Time frame: At 5years, 10years after enrollment
Risk factors for disease progression in the active surveillance group
To evaluate the risk factors for progression to thyroid cancer based on demographic factors, serial ultrasound findings, blood markers, and molecular pathological characteristics at each follow-up visit.
Time frame: At 5years, 10years after enrollment
Rate of conversion to surgery without disease progression in the active surveillance group
To estimate the proportion of patients in the active surveillance group who undergo surgery without clinical evidence of progression to thyroid cancer, evaluated at each follow-up visit.
Time frame: At 5years, 10years after enrollment
Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group
The outcome will be measured as the proportion (%) of patients in each group who experience disease progression at each follow-up visit. Disease progression is defined as meeting any of the following criteria: 1. an increase in tumor size of ≥3 mm in maximum diameter, or ≥2 mm in two perpendicular diameters; 2. a cytopathological diagnosis of a new thyroid cancer lesion; 3. a cytopathological diagnosis of cervical lymph node metastasis; 4. clinical or radiological suspicion of distant metastasis.
Time frame: At 5years, 10years after enrollment
Factors influencing treatment decision-making
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment.
Time frame: At 5years, 10years after enrollment
Decision Conflict Scale Score
The level of confidence in decision-making will be assessed at each follow-up visit using the Decision Conflict Scale. This questionnaire evaluates the level of agreement with statements related to treatment plan decisions on a scale from 0 (strongly disagree) to 5 (strongly agree), in 1-point increments. Higher scores indicate greater confidence and certainty in the decision-making process.
Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Shared Decision-Making Satisfaction Score
To assess patient satisfaction with the shared decision-making process with healthcare providers. Satisfaction is measured using a questionnaire rated on a scale from 0 (very dissatisfied) to 10 (very satisfied), with 1-point increments. Higher scores indicate greater satisfaction with the collaborative decision-making process.
Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.